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Quality of LifeDYSMOSTIMNCT03476265

Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motility

A study testing Electrical Stimulation of the Lower Esophageal Sphincter in people with Quality of Life and Dysphagia, run by Austrian Society Of Surgical Oncology at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to evaluate gastroesophageal reflux disease - health related quality of life (GERD-HRQL) after electrical stimulation of the lower esophageal sphincter (LES) in patients with gastroesophageal reflux disease (GERD) and esophageal dysmotility. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Electrical Stimulation of the Lower Esophageal Sphincter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
1 siteAustria
Study dates
1 May 2017to 15 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject is indicated for LES Stimulation and plans to undergo antireflux surgery.
  • Subject is meeting the criteria of IEM (Chicago classification v3.0)
  • Subject provides signed informed consent

Who cannot join

  • Subject is within a vulnerable population or is unable to understand the informed consent.
  • Subject is unwilling to attend follow-up visits.

Trial locations and contacts

1 site in 1 country.

Austria1 site

  • Medical University of Vienna

    Vienna, 1090

Other trials in Austria

About this study

Official title: Evaluation of Gastroesophageal Reflux Disease - Health Related Quality of Life After Lower Esophageal Sphincter (LES) Stimulation in Patients With Ineffective Esophageal Motilitygus (IEM)

The aim of this study is to evaluate gastroesophageal reflux disease - health related quality of life (GERD-HRQL) after electrical stimulation of the lower esophageal sphincter (LES) in patients with gastroesophageal reflux disease (GERD) and esophageal dysmotility.

Read the detailed description

Background The growing burden of gastroesophageal reflux disease (GERD) still impacts healthcare costs intensively. Although the treatment with proton pump inhibitor (PPI) is effective in many cases, surgical treatment remains relevant due to a large amount of PPI refractory GERD. Laparoscopic fundoplication (LF) is considered as standard procedure, but this type of surgery is linked to side effects as dysphagia, gas bloating and inability to belch. Especially patients with ineffective esophageal motility (IEM) are prone to postoperative dysphagia after LF. Lower esophageal sphincter electrical stimulation (LES-EST) was introduced as an alternative technique to avoid side effects of LF. Rodriquez et al. have bee demonstrated that LES-EST significantly raises the LES pressure and improved GERD symptoms such as heartburn and regurgitation. The advantage of this procedure is that the anatomy of the esophageal-gastric junction is not altered dramatically. Notably, patients with severely disordered esophageal peristalsis will benefit from this low-risk profile.

After successful implementation of this technique at the Medical University of Vienna (EK 1149/2014), a prospective evaluation of data with the well established gastroesophageal reflux disease - health-related quality of life is next. Patients with esophageal motility disorder, who undergo LES-EST, will be investigated towards side effects such as gas-bloating, inability to belch, flatulence and dysphagia.

Being tested
Electrical Stimulation of the Lower Esophageal Sphincter
Medical subject headings
Deglutition Disorders, Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrical Stimulation of the Lower Esophageal SphincterDevice

    Laparoscopic implantation of an electrical stimulation device to perform an electrical sphincter augmentation for the treatment of GERD.

Study groups in NCT03476265
Study groupRoleWhat they receive
Ineffective Esophageal Motility and GERDExperimentalPatients with gastroesophageal reflux disease (GERD) refractory to proton pump inhibitors (PPI) and ineffective esophageal motility (IEM) according to the Chicago classification v3.0.
Receives: Device: Electrical Stimulation of the Lower Esophageal Sphincter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in patient's GERD-HRQL from baseline to 6 months.

    GERD related quality of life (QoL) is assessed with the "gastroesophageal reflux disease - health related quality of life" (GERD-HRQL) questionnaire. QoL is measured at baseline and at six months afters surgery. At unscheduled follow up visits QoL assessment is non-compulsory. The GERD-HRQL score consists of ten questions regarding GERD-related symptoms and their influence on QoL. Total scores range from 0 to 75. Testing will be split to a questionnaire for heartburn (0-30) and a questionnaire for regurgitation (0-30), the two cardinal symptoms of GERD. Lower scores indicate better QoL. This questionnaire was designed to objectively quantify symptom severity and was described validated by Velanovich et al and since then is the most frequently used GERD specific questionnaire.

    Measured: 6 months

Secondary outcomes (3)

  1. Change of pH-metry from baseline to 6 months follow up

    Total % of time of pH < 4 in 24 hours impedance/pH reflux monitoring (ZepHr®, Sandhill Scientific Inc., USA).

    Measured: 6 months

  2. Change of number of reflux events >1minute and >5 minute duration from baseline to 6 months follow up

    24 hours impedance/pH reflux monitoring (ZepHr®, Sandhill Scientific Inc., USA).

    Measured: 6 months

  3. Distal Contractile Integral

    High-resolution impedance manometry (InSIGHT Ultima®, Sandhill Scientific Inc., USA)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2018
  2. Study start1 May 2017
  3. Primary completion15 Jan 2018
  4. Study completion15 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03476265
Sponsor's protocol ID
AUT-DYSMOSTIM-01
Acronym
DYSMOSTIM
Status last verified
Jul 2019
First submitted
13 Mar 2018
Last updated
5 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Peery AF, Crockett SD, Barritt AS, Dellon ES, Eluri S, Gangarosa LM, Jensen ET, Lund JL, Pasricha S, Runge T, Schmidt M, Shaheen NJ, Sandler RS. Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States. Gastroenterology. 2015 Dec;149(7):1731-1741.e3. doi: 10.1053/j.gastro.2015.08.045. Epub 2015 Aug 29.

    PubMed 26327134

  • Subramanian CR, Triadafilopoulos G. Refractory gastroesophageal reflux disease. Gastroenterol Rep (Oxf). 2015 Feb;3(1):41-53. doi: 10.1093/gastro/gou061. Epub 2014 Sep 30.

    PubMed 25274499

  • Richter JE. Gastroesophageal reflux disease treatment: side effects and complications of fundoplication. Clin Gastroenterol Hepatol. 2013 May;11(5):465-71; quiz e39. doi: 10.1016/j.cgh.2012.12.006. Epub 2012 Dec 23.

    PubMed 23267868

  • Novitsky YW, Wong J, Kercher KW, Litwin DE, Swanstrom LL, Heniford BT. Severely disordered esophageal peristalsis is not a contraindication to laparoscopic Nissen fundoplication. Surg Endosc. 2007 Jun;21(6):950-4. doi: 10.1007/s00464-006-9126-3. Epub 2006 Dec 20.

    PubMed 17177077

  • Rodriguez L, Rodriguez P, Neto MG, Ayala JC, Saba J, Berel D, Conklin J, Soffer E. Short-term electrical stimulation of the lower esophageal sphincter increases sphincter pressure in patients with gastroesophageal reflux disease. Neurogastroenterol Motil. 2012 May;24(5):446-50, e213. doi: 10.1111/j.1365-2982.2012.01878.x. Epub 2012 Jan 31.

    PubMed 22292889

  • Rodriguez L, Rodriguez PA, Gomez B, Netto MG, Crowell MD, Soffer E. Electrical stimulation therapy of the lower esophageal sphincter is successful in treating GERD: long-term 3-year results. Surg Endosc. 2016 Jul;30(7):2666-72. doi: 10.1007/s00464-015-4539-5. Epub 2015 Oct 20.

    PubMed 26487200

  • Velanovich V. The development of the GERD-HRQL symptom severity instrument. Dis Esophagus. 2007;20(2):130-4. doi: 10.1111/j.1442-2050.2007.00658.x.

    PubMed 17439596

  • Velanovich V. Comparison of generic (SF-36) vs. disease-specific (GERD-HRQL) quality-of-life scales for gastroesophageal reflux disease. J Gastrointest Surg. 1998 Mar-Apr;2(2):141-5. doi: 10.1016/s1091-255x(98)80004-8.

    PubMed 9834409

  • Paireder M, Kristo I, Asari R, Jomrich G, Steindl J, Rieder E, Schoppmann SF. Effect of electrical stimulation therapy of the lower esophageal sphincter in GERD patients with ineffective esophageal motility. Surg Endosc. 2021 Nov;35(11):6101-6107. doi: 10.1007/s00464-020-08104-3. Epub 2020 Oct 30.

    PubMed 33128080

Questions about this trial

What is this clinical trial studying?

A study testing Electrical Stimulation of the Lower Esophageal Sphincter in people with Quality of Life and Dysphagia, run by Austrian Society Of Surgical Oncology at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in patient's GERD-HRQL from baseline to 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03476265, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.

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